Blogs

Focus On Regulation

Dutch competition authority imposes fine on company for deleted chat messages during a dawn raid

The Dutch competition authority (“ACM“) recently confirmed that the obligation to cooperate fully with an inspection/during a dawn raid is of utmost importance and of great...

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European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding...

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Algorithms in the spotlight of antitrust authorities

Joint study by the Bundeskartellamt (German Cartel Office) and the Autorité de la concurrence (French Competition Authority) indicates need for higher compliance standards.

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Heads of Medicines Agencies publishes practical guidance on nitrosamines

In late October 2019, the Co-ordination Group for Mutual Recognition and Decentralised procedures – Human (CMDh) of the Heads of Medicines Agencies (HMA) published a practical...

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European Medicines Agency’s new guide on the wording of therapeutic indication

On 21 October 2019, the European Medicines Agency (EMA) published a guide for assessors of centralised applications for marketing authorisation. The guide focuses on the wording used in...

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